This is a phase II, multicentre clinical study investigating HS-20093 or SHR2554 in combination with a Novel Hormonal Agent (NHA) for advanced prostate cancer. The trial comprises two cohorts.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
218
Nanjing Drum Tower Hospital
Nanjing, Jiangsu, China
Tianjin Medical University Cancer Institute and Hospital
Tianjin, Tianjin Municipality, China
Cohort 1: 6-month undetectable Prostate Specific Antigen (PSA) rate.
Time frame: 6 months.
Cohort 2: Prostate Specific Antigen (PSA) response rate.
Time frame: About 2 years.
Cohort 2: Adverse events (AEs).
Time frame: About 2 years.
Cohort 2: Dose-limiting toxicity (DLT).
Time frame: About 28 days.
Radiographic Progression-Free Survival (rPFS).
Time frame: About 2 years.
Time to Prostate Specific Antigen (PSA) progression.
Time frame: About 2 years.
Time to Next Symptomatic Skeletal Event (SSE).
Time frame: About 2 years.
Time to Next Antineoplastic Therapy (TTNT).
Time frame: About 2 years.
Objective response rate (ORR).
Time frame: About 2 years.
Cohort 1: Adverse events (AEs).
Time frame: About 2 years.
Disease control rate (DCR).
Time frame: About 2 years.
Duration of response (DoR).
Time frame: About 2 years.
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SHR2554 tablet.
Enzalutamide tablet.
Darotamine capsule.
Overall Survival (OS).
Time frame: About 2 years.